7
Research and Policy Opportunities

OVERVIEW

Contributors to previous chapters have addressed research and policy opportunities in food safety oversight, surveillance, and disease reporting in protecting the food supply. Additional research and policy issues were raised in workshop presentations that focused on animal health, food defense, and food safety science.

Dr. Lonnie King, dean of the College of Veterinary Medicine at Michigan State University, presented key findings from the recently published report, Animal Health at the Crossroads (2005). This chapter begins with an excerpt from this report, which explored the critical linkage between animal and human health illustrated in case studies of key animal diseases. The study committee, assembled by the National Research Council (NRC), evaluated existing prevention and detection systems and identified opportunities and barriers to their improvement; many of their findings directly address the reduction of foodborne illness.

The chapter concludes with a paper by Dr. Francis Busta, director of the National Center for Food Protection and Defense (NCFPD), who describes research to protect the food supply from deliberate harm and to mitigate the effects of such an attack. Recognizing that many of the same tools and strategies could be used to guard against any incident of food adulteration, whether accidental or deliberate, Busta emphasizes techniques that address key questions raised by a foodborne attack: how it was staged, which threat agent was used, what decontamination and other public health measures should be taken, and how to inform the public about the incident.

The workshop concluded with a presentation by Dr. Sanford Miller, who noted the profound influence of such nonscientific issues on perceptions of risks



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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary 7 Research and Policy Opportunities OVERVIEW Contributors to previous chapters have addressed research and policy opportunities in food safety oversight, surveillance, and disease reporting in protecting the food supply. Additional research and policy issues were raised in workshop presentations that focused on animal health, food defense, and food safety science. Dr. Lonnie King, dean of the College of Veterinary Medicine at Michigan State University, presented key findings from the recently published report, Animal Health at the Crossroads (2005). This chapter begins with an excerpt from this report, which explored the critical linkage between animal and human health illustrated in case studies of key animal diseases. The study committee, assembled by the National Research Council (NRC), evaluated existing prevention and detection systems and identified opportunities and barriers to their improvement; many of their findings directly address the reduction of foodborne illness. The chapter concludes with a paper by Dr. Francis Busta, director of the National Center for Food Protection and Defense (NCFPD), who describes research to protect the food supply from deliberate harm and to mitigate the effects of such an attack. Recognizing that many of the same tools and strategies could be used to guard against any incident of food adulteration, whether accidental or deliberate, Busta emphasizes techniques that address key questions raised by a foodborne attack: how it was staged, which threat agent was used, what decontamination and other public health measures should be taken, and how to inform the public about the incident. The workshop concluded with a presentation by Dr. Sanford Miller, who noted the profound influence of such nonscientific issues on perceptions of risks

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary to the food supply. Safety is not a biological property of food, Miller contended, but an intellectual concept influenced as much by the political, economic, and social factors that determine our perception of risk as by any quantifiable measure of hazard. Thus efforts to improve food safety must not only identify foodborne threats, but also translate these discoveries into regulation, communication, and legislation that accurately reflect the risks such threats pose to society. Meeting these challenges is the goal of the nascent field of food safety science, which integrates nutrition, microbiology, toxicology, molecular biology, genetics, functional biology, and conventional food science, and brings these disciplines to bear on the problem of ensuring a safe food supply through the practice of risk assessment. “We all feel comfortable talking about science,” Miller observed, “but the moment comes when science has to be translated into risk, and risk has to be translated into some kind of public policy action.” The food safety scientist he envisions will use sophisticated, risk-based, scientifically sound models to determine how best to protect our food supply. ANIMAL HEALTH AT THE CROSSROADS1 Committee on Assessing the Nation’s Framework for Addressing Animal Diseases2 National Research Council Synopsis The national framework to safeguard animal health is of paramount importance to the U.S. economy, public health, and food supply. To strengthen the existing framework, the nation should establish a high-level, authoritative mechanism to coordinate interactions between the private sector and local, state, and federal agencies. New tools for detection, diagnosis, and risk analysis need to be developed now, and the capacity of the existing animal health laboratory network should be expanded for both routine and emergency diagnostic uses. Integrative animal health research programs, in which veterinary and medical scientists can work as collaborators, should be established. Colleges of veterinary medicine must lead an effort to develop a national animal health education plan to educate and train individuals from all sectors (from animal handlers to pathologists) in disease prevention and early detection, and to recruit veterinary students into careers in public health, food systems, biomedical research, diagnostic laboratory 1 Reprinted from NRC (2005). Animal Health at the Crossroads. Washington, D.C.: The National Academies Press. 2 Board on Agriculture and Natural Resources, Division on Earth and Life Studies.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary investigation, pathology, epidemiology, ecosystem health, and food-animal practice. The United States must address the importation and health of exotic and wild-caught animals and commit itself to shared leadership roles with other countries and international organizations that address animal disease agents. Finally, a collective effort should be made to raise the level of public awareness about the importance of animal health and of the national investment in the framework to safeguard animal health. Background Animal health has broad implications, ranging from the health of individual animals and the well-being of human communities to issues of global security. Many people would be surprised by the assertion that our nation’s highest priorities must include animal health, yet we must recognize and act on this reality to ensure a safe and healthy future. Among other things, animal diseases critically affect the adequacy of the food supply for a growing world population, and they have huge implications for global trade and commerce. Moreover, many animal disease agents are zoonotic—meaning that they are transmittable to humans—so they have dramatic implications for human health and safety, and for animal disease prevention. Animal disease prevention and control is crucial to improving public health on a global scale. Additionally, in an era of growing concern about the threat of terrorism, the potential impact of the intentional use of animal disease agents to cause morbidity and mortality, as well as economic damage, is enormous. The U.S. animal health framework includes many federal, state, and local agencies that generally have differing mandates of law, and numerous other public and private entities and international organizations, each with its own goals and objectives, each responsible for maintaining animal health. In the past, this framework has been reasonably effective in responding to a range of demands and challenges. In recent years, however, animal health has been challenged in a manner not previously experienced. Today animal health is at a crossroads. The risk of disease is coming from many directions, including the globalization of commerce, the restructuring and consolidation of global food and agriculture productions into larger commercial units, the interactions of humans and companion animals, human incursions into wildlife habitats, and the threat of bioterrorism. The impacts of these sources of risk are evident in recent disease events (Box 7-1). Given the changing nature of the risks with which the framework must cope, it is unlikely that the current philosophy on how to protect animal health will be adequate in the future. The risks of animal disease must be dealt with not only in terms of protecting individual species of animals from specific pathogens, but also in a broader context that includes anticipating the emergence and spread of disease on local and global scales, and recognizing the relationships of animal

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary BOX 7-1 Impacts from Recent Disease Events In 2003, severe acute respiratory syndrome (SARS) sent a global shockwave, affecting countries with even few cases, such as the United States. Although SARS infected only 8,000 people globally, the disease spread to 30 countries and its effect on the global economy totaled $8 billion. The United Kingdom’s economy has not yet recovered from a foot-and-mouth disease (FMD) outbreak in 2001, which also reverberated around the world, affecting both agricultural and nonagricultural interests (such as rural businesses and tourism/recreational use of the countryside). A single case of mad cow disease (bovine spongiform encephalopathy or BSE) in Washington State on December 23, 2003, had an immediate market impact and severe, sustained economic losses due to trade restrictions on U.S. cattle and their products. The infected animal was discovered as part of the government’s policy to routinely test downer cattle for BSE, which has been linked to a new variant of Creutzfeldt-Jakob disease, a fatal neurological illness in humans. In June 2005, a second case of BSE was confirmed in the United States. In 2004, a new strain of highly pathogenic avian influenza (AI) spread through Southeast Asia, resulting in the loss of more than 100 million birds through mortality and control measures and dozens of human cases, highlighting the unpredictable and potentially catastrophic nature of emerging zoonotic disease. This new influenza strain was transmitted from birds to people, raising concern that it might be capable of evolving into the next pandemic influenza strain. In 1999, West Nile virus (WNV), an arbovirus similar to St. Louis encephalitis virus, emerged for the first time in the Western Hemisphere in New York from an unknown source. Over the next five years it swept across the continental United States, Canada, Mexico, Central America, and several Caribbean islands, carried by mosquito vectors infecting wild birds. In the United States in 2004, the virus was detected in approximately 2,250 humans (40 states), 1,250 horses (36 states), nearly 7,000 wild birds, mostly corvids (45 states), and in much smaller numbers in a few other animal species. While these numbers are substantially below those that occurred in the first wave of infection, WNV bodes to become endemic in wild birds and an ongoing source of infection transmitted to other species by mosquito vectors.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary disease to human health and the environment. To address animal disease in that context, the animal health framework will have to be more flexible and inclusive of expertise available from research, medical, and public health communities, and from the fields of environmental sciences and public policy, among others. To respond comprehensively to new threats, the responsibilities of the framework’s many actors will need to be clearly defined and their actions better coordinated. Admittedly, the process of transformation is difficult during periods when disease outbreaks consume all attention. However, now is the time to strengthen the structure of the current system and to instigate a change in its culture, so that it will be capable of responding effectively in the future. This report explores the evolving challenges facing animal health, identifies vulnerabilities and gaps in the animal health framework, and recommends steps needed to fill gaps and improve the effectiveness of the framework. Committee’s Statement of Task Recent animal and human health events have illustrated that the national system for protecting animal health is now facing a continuum of host-parasite relationships involving public health, wildlife, ecosystems, and food systems, operating in an increasingly complex global context (see Figure 7-1). Adapting the current framework to this new reality will be both a major challenge and a national imperative. In recognition of the changing influences on animal health, the National Academies developed a concept for a three-phase analysis of the U.S. system for dealing with animal diseases and committed institutional funds to launch the first phase of the study. This report, which embodies the first phase of the study, presents an overview of the animal health framework and examines the framework’s overall operation in the prevention, detection, and diagnosis of animal diseases. The proposed second phase of the study (pending supplemental external support) will focus on surveillance and monitoring capabilities, and the proposed third phase will focus on response and recovery from an animal disease epidemic. Although surveillance and monitoring play an important part in prevention, detection, and diagnosis, the second phase of the study, as currently envisioned, will analyze in greater depth the system’s capacity and needs for surveillance and monitoring of animal diseases. Relative to its respective focus, each phase of the study will: (1) review the state and quality of the current system for dealing with animal disease; (2) identify key opportunities and barriers to successfully preventing and controlling animal diseases; and (3) identify immediate courses of action for those on the front lines. This first phase of the study did not attempt an in-depth review of the effectiveness of each individual component of the framework or of any specific agency involved in safeguarding animal health—a task well beyond the scope of this

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary FIGURE 7-1 Interactions of emerging infectious diseases (EIDs) with a continuum that includes wildlife, domestic animal, and human populations. Few diseases affect exclusively one group, and the complex relations among host populations set the scene for disease emergence. Examples of EIDs that overlap these categories include Lyme disease (wildlife to domestic animals and humans); bovine tuberculosis (between domestic animals and wildlife); Escherichia coli O157:H7 (between domestic animals and humans); and Nipah virus and rabies (all three categories). Companion animals are categorized in the domestic animal section of the continuum. effort—but did examine the effectiveness of the framework as a whole in relation to different animal disease scenarios. In doing so, it sought to identify ways to improve the framework. Finally, although animals are subject to the same causes of disease as humans—that is, diseases with chemical, physical, microbial, or genetic causes— the study focuses primarily on infectious diseases, as directed by the Statement of Task (see Chapter 1, Box 1-1 from the NRC report Animal Health at the Crossroads, for the committee’s Statement of Task). This focus arises from concern about the growing threat posed by the spread of emerging infectious disease associated with the increasing global interconnectedness of domestic animals, wildlife, and humans, and by the possibility of bioterrorism. Overview of the Animal Health Framework The essential components of the animal health framework include the following:

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary People on the “front lines” of the animal production unit, animal habitat, or companion animal household (including ranch and farm workers, producers, feeders, breeders, park rangers, companion animal owners, wildlife rehabilitators, and zoo keepers); Veterinarians and other sources of professional advice and care for health-related issues (such as universities and diagnostic laboratories); Federal, state, and local animal health and public health agencies (consisting mainly of state departments of agriculture and state diagnostics laboratories within universities and elsewhere in state governments, and numerous bureaus and offices within over 10 federal departments, but primarily within the U.S. Departments of Agriculture, Homeland Security, and Health and Human Services); International collaborations among agencies, organizations, and governments (such as the World Organization for Animal Health and the World Health Organization); and Supporting institutions, industries, and organizations (including educators, researchers, and the public health and intelligence communities). Because of the very large number of actors responsible in some way for safeguarding animal health, it is not surprising that effective coordination is a major challenge. In a retrospective analysis of numerous specific animal disease situations, the committee examined the collective capabilities and limitations of the framework with respect to its effectiveness in the prevention, detection, and diagnosis of animal diseases. Several weaknesses, needs, and gaps were consistently encountered in the framework’s response to a broad spectrum of disease types including exotic Newcastle disease (END), foot-and-mouth disease (FMD), monkeypox, bovine spongiform encephalopathy (BSE), chronic wasting disease (CWD), West Nile virus (WNV), avian influenza (AI), and diseases caused by coronavirus. This examination led the committee to the following conclusions: The framework for animal health lacks adequate systems and tools for analyzing and managing risk, and planning for outbreaks. Efforts to develop and validate diagnostic assays and advanced vaccines of a recognized pathogen need to occur more rapidly. The workforce on the front lines of animal care is not adequately educated and trained to deal with animal disease issues, and there is a shortage of veterinarians in the workforce for animal disease prevention, detection, and diagnosis. Greater collaboration between public health and animal health officials can accelerate the detection and diagnosis of animal diseases. The broad capabilities that exist in universities, industry, state entities, veterinary diagnostic laboratories, and other local animal health infrastructure are underutilized.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary The lack of collaboration between the biomedical and veterinary communities is a lost opportunity that impedes the effectiveness of the framework. There is a need for state-of-the-art equipment and biocontainment facilities for both research and diagnostics. Federal, state, and private entities responsible for animal health have different authorities, and there are gaps in that authority, particularly in relation to wildlife disease. The past success of international collaboration in responding to animal disease demonstrates its importance in addressing animal diseases. Recommendations for Strengthening the Animal Health Framework Reflecting on the structure of the framework and based on the findings of its analysis of past animal health events, the committee offers the following 11 recommendations as potential opportunities for strengthening the framework’s capabilities in the prevention, detection, and diagnosis of animal diseases. Coordination of Framework Components Recommendation 1: The nation should establish a high-level, centralized, authoritative, and accountable coordinating mechanism or focal point for engaging and enhancing partnerships among local, state, and federal agencies and the private sector. There is a need for a strategic focal point to enhance partnerships and to integrate all stakeholders into a cohesive whole. Many federal agencies are responsible for parts of animal health policy, with significant overlaps in the programmatic functions among them and also between federal agencies and programs directed through states or animal health organizations. On the other hand, there are also gaps in responsibility. Of particular concern is the paucity of federal oversight of the nonlivestock, animal-centered aspects of zoonotic diseases. While there are several possible models for improved coordination in prevention, detection, and diagnosis, the committee did not recommend options for a specific system-wide mechanism, in part because it has only examined the animal health framework from the partial perspective of prevention, detection, and diagnosis. Regardless of how a central coordinating mechanism or focal point is implemented, it will need to promote effective communication among various stakeholders and with the public during and outside episodes of animal disease outbreaks. Opportunities for information-sharing between agencies using electronic information systems should be developed. A methodic effort should be made to identify and link key databases and establish protocols for contributing data and generating alerts.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary Technological Tools for Preventing, Detecting, and Diagnosing Animal Diseases Recommendation 2: Agencies and institutions—including the U.S. Department of Agriculture (USDA) and the Department of Homeland Security (DHS)—responsible for protecting animal industries, wildlife, and associated economies should encourage and support rapid development, validation, and adoption of new technologies and scientific tools for the detection, diagnosis, and prevention of animal diseases and zoonoses. The current animal health framework has been slow to evaluate, validate, and implement new scientific tools and technologies that could significantly enhance animal disease prevention, detection, and diagnostic capabilities for the United States. Despite a recent surge in activity related to post-September 11 homeland security efforts and associated focused funding, the active review and implementation of advancing technologies has been inadequate to protect and enhance the health of the country’s animal populations and related economic systems. Technological advances—such as immune system modulators, animal-embedded monitoring (chips embedded underneath an animal’s skin to monitor temperature and other physiological indices), and differential vaccines as prevention strategies, as well as a range of rapid, automated, sensitive, and portable sampling and assay systems for early warning and reliable diagnosis—have not been adequately exploited by the current animal health framework. Early biodefense warning systems, such as DHS’ BioWatch or private industry’s gene-based anthrax testing, are designed for rapid detection and identification of key pathogens by sampling air in public environments. These systems have been operating since early 2003 and are meant to assist public health experts in rapidly responding to the intentional release of a biologic agent (DHS, 2004a). Early warning technologies have not yet been adequately evaluated by the animal health infrastructure. Scientific Preparedness for Diagnosing Animal Diseases: Laboratory Capacity and Capability Recommendation 3: The animal health laboratory network should be expanded and strengthened to ensure sufficient capability and capacity for both routine and emergency diagnostic needs and to ensure a robust linkage of all components (federal, state, university, and commercial laboratories) involved in the diagnosis of animal and zoonotic diseases. Laboratory diagnosis of animal diseases in the United States involves federal, state, university, and commercial entities. The committee focused its assessment on the condition of publicly funded laboratories and the current operational status of national laboratory networks. Funding and implementation of the pilot National Animal Health Laboratory Network (NAHLN) in June 2002 was an

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary important and beneficial paradigm shift from an exclusive federal system to one with shared state and federal responsibility for foreign animal disease diagnosis. The pilot NAHLN involved 12 state/university diagnostic laboratories approved for disease testing using existing and newly developed assays. The NAHLN is no longer a pilot program and has since been redefined to include all laboratories performing contract work for the USDA on BSE, CWD, scrapie, AI, END, and classical swine fever (CSF). However, the current network lacks surge capacity and is not prepared for disease agents and toxins outside the narrow list of diseases that provided an initial focus for network development (for example, FMD or Rift Valley fever). In addition, implementing this recommendation will require the creation of formal linkages and operational relationships between the NAHLN, state and university veterinary diagnostic laboratories, and the Laboratory Response Network for Bioterrorism (LRN), established by the U.S. Centers for Disease Control and Prevention (CDC) in 1995 to improve the response capabilities of the nation’s public health laboratory infrastructure. It will require development of additional biosafety level 3 (BSL-3) necropsy and laboratory capacity. Population-based diagnostic and detection systems also will need to be developed by diagnostic laboratories in order to provide the broad diagnostic outlook necessary for detection of new and emerging diseases. Animal Health Research Recommendation 4: Federal agencies involved in biomedical research (both human and veterinary) should establish a method to jointly fund new, competitive, comprehensive, and integrated animal health research programs; ensure that veterinary and medical scientists can work as collaborators; and enhance research, both domestically and internationally, on the detection, diagnosis, and prevention of animal and zoonotic disease encompassing both animal and human hosts. This process might be modeled on the National Institutes of Health (NIH)-administered Interagency Comparative Medicine Research Program, an interagency task force model, or some comparable process that promotes this type of cooperative research agenda. This recommendation builds on the 2003 Institute of Medicine (IOM) report Microbial Threats to Health: Emergence, Detection, and Response, which states: “NIH should develop a comprehensive research agenda for infectious disease prevention and control in collaboration with other federal research institutions and laboratories (e.g., CDC, the U.S. Department of Defense, Department of Energy, the National Science Foundation), academia, and industry” (IOM, 2003). Currently, basic and translational research related to prevention, detection, and diagnosis of animal and zoonotic diseases is being conducted by a complex array of government, academic, and private institutions and there is minimal coordina-

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary tion, if any, in setting priorities to ensure that important research topics are not overlooked and to ensure the most effective use of scarce resources. A forthcoming National Research Council (NRC) report Critical Needs for Research in Veterinary Science will contain a more in-depth assessment of national needs for research in animal health. Recommendation 5: To strengthen the animal health and zoonotic disease research infrastructure, the committee recommends that competitive grants be made available to scientists to upgrade equipment for animal disease research and that the nation construct and maintain government and university biosafety level 3 (BSL-3 and BSL-3 Ag)3 facilities for livestock (including large animals), poultry, and wildlife. Access to state-of-the-art equipment and technological tools is essential to successfully conduct the research needed to understand, prevent, and control emerging or exotic infectious agents. When a new infectious agent is suspected, efforts must be made to first rapidly define and characterize the agent, under strict biocontainment conditions. At present, few BSL-3 or BSL-3 Ag facilities are available strategically throughout the United States or are equipped and prepared for research on diseases of livestock, poultry, or wildlife, including zoonoses that require BSL-3 biocontainment. Additional BSL-3 facilities are needed for research and surge capacity (in case of outbreaks) for detection, diagnosis, and prevention of many zoonotic and all exotic animal pathogens. International Interdependence and Collaboration Recommendation 6: The United States should commit resources and develop new shared leadership roles with other countries and international organizations in creating global systems for preventing, detecting, and diagnosing known and emerging diseases, disease agents, and disease threats as they relate to animal and public health. As the United States and the rest of the world become increasingly interdependent, it is essential to identify animal disease risk factors as they emerge and to focus more attention on the sources and precursors of infections. Taken collectively, the recent experience with SARS, West Nile virus, and monkeypox leads to the inescapable conclusion that globalization, population growth, and expansion of human activity into previously unoccupied habitats has essentially connected the United States to potential zoonotic and nonzoonotic pathogens residing throughout the world. This necessitates coordinated international collabo- 3 Containment facilities are classified as Biosafety Levels 1 through 4, with 4 being the most restrictive. Biosafety level 3 (BSL-3 or BSL-3 Ag) provides the high degree of containment that is needed when studying a variety of organisms with a recognized potential for significant detrimental impact on animal or human health or on natural ecosystems.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary United States is inconsistent and ineffective, and there is a disturbing lack of standardized testing of the health status of exotic animals at the point of origin and in companion animal shops, trade fairs, and other venues. Considering that the emergence of new disease agents occurs most frequently at species interfaces, monkeypox is not likely to be the last zoonotic agent to emerge from an exotic animal in the United States. Addressing Future Animal Disease Risks Recommendation 8: The USDA, DHS, Department of Health and Human Services, and state animal and public health agencies and laboratories should improve, expand, and formalize the use of predictive, risk-based tools and models to develop prevention, detection, diagnostic, and biosecurity systems and strategies for indigenous, exotic, and emerging animal diseases. There has been increased recognition and use of well-structured and scientifically based mathematical, epidemiological, and risk analysis models and tools to define acceptable risks and mitigation strategies that can assist in policy and science-based decision making. Examples include models of the spread of FMD during the UK epidemic, and an assessment of the risk of BSE to U.S. agriculture, developed by Harvard University’s Center for Risk Analysis for the USDA (Cohen et al., 2003; Haydon et al., 2004). Risk analysis and modeling have been criticized, mainly on the basis of insufficient scientific data or inappropriate assumptions. Therefore, efforts to develop scientific data on disease transmission, effectiveness of control programs, economic evaluation, and quantitative assessment of all factors involved in making policies and regulations should be a priority of the animal health infrastructure, working in collaboration with academia, industry, and global trade partners. Threats from bioterrorism, emerging diseases, and foreign animal disease introductions add urgency to preventing or minimizing catastrophic consequences to the United States, other nations, and the global economy. Education and training of professionals to assess, manage, and communicate risk of animal disease and improved information available to stakeholders, including producers and the public, are important aspects of effective infrastructure that supports risk-based approaches. Education and Training Recommendation 9: Industry, producers, the American Veterinary Medical Association (AVMA), government agencies, and colleges of veterinary medicine should build veterinary capacity through both recruitment and preparation of additional veterinary graduates into careers in

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary public health, food systems, biomedical research, diagnostic laboratory investigation, pathology, epidemiology, ecosystem health, and food animal practice. There are insufficient graduates to meet the needs in a number of major and distinct fields of veterinary medicine dealing with various species of food-animals, rural practice (mixed domestic animals), ecosystem health (including wildlife disease and conservation biology), public health, the many dimensions of the food system, and biomedical science. In addition, veterinary graduates are not adequately prepared to deal with foreign animal diseases, public health, and ecosystem health, without further postgraduate studies. According to the Association of American Veterinary Medical Colleges (AAVMC), the 28 veterinary colleges in the United States graduate approximately 2,300 veterinarians per year and are currently unable to keep up with societal needs in private or public practice. There has been a steady decline in the number of rural practitioners and of veterinarians employed in regulatory agencies. The USDA, underserved at present, predicts a shortfall of 584 veterinarians on its staff by 2007. Fifty percent of U.S. Public Health Service veterinarians are currently eligible for retirement. Too few veterinary students are choosing to specialize in basic biomedical science or pathology, as noted in the recently published NRC report National Need and Priorities for Veterinarians in Biomedical Research, which suggests a strategy for recruiting and preparing more veterinarians for careers in laboratory animal medicine, comparative medicine, and comparative pathology (NRC, 2004). This committee endorses the recommendations of that report. One strategy for building veterinary capacity is to design and implement training and educational curricula to better address these underserved areas of animal health. The Veterinary Medical Education and Workforce Development Act of 2004, which amends the Public Health Service Act, will be a useful first step that establishes a competitive grants program to build capacity in veterinary medical education and expands the workforce of veterinarians engaged in public health practice and biomedical research. Recommendation 10: The USDA, state animal health agencies, the AVMA, and colleges and schools of veterinary medicine and departments of animal science should develop a national animal health education plan focusing on education and training of individuals from all sectors involved in disease prevention and early detection through day-to-day oversight of animals. Responsibility for implementing the educational plan would fall on those at the local level. Strong and well-functioning front-line detection is provided by animal handlers and personnel working with animals on a day-to-day basis. This backbone for effectively preventing animal disease outbreaks requires education and training to include awareness and recognition of clinical signs, as well as an

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary elementary understanding of disease transmission and prevention. In addition, those with day-to-day oversight of animals need to understand the methods and responsibilities for reporting the signs of foreign and exotic animal diseases. Basic multilingual education and training are necessary for those with such direct oversight of animals, whereas more in-depth education to promote a greater depth and breadth of understanding of transmission and prevention is required for managers and owners. Improving Public Awareness of the Economic, Social, and Human Health Effects of Animal Diseases Recommendation 11: The government, private sector, and professional and industry associations should collectively educate and raise the level of awareness of the general public about the importance of public and private investment to strengthen the animal health framework. Increased public awareness is critical in supporting and implementing transformations needed to strengthen the framework against animal disease risks. The lack of cohesive national advocacy for public health issues generally creates a much more difficult environment in which to increase attention and investment in the framework for preventing, detecting, and diagnosing animal diseases. The recent outbreaks of FMD, SARS, AI, and BSE are all reminders of the threats such diseases pose to the U.S. food supply, global economy, public health, and confidence in the safety of the food supply. The entire food and fiber system—including farm inputs, processing, manufacturing, exporting, and related services—is one of the largest sectors of the U.S. economy and accounts for output of over $2 trillion dollars, generating $1.24 trillion in added value, and 12.3 percent of total gross domestic product in 2001 (USDA, 2003). Nearly 17 percent of all U.S. workers are employed by the food and fiber system (USDA, 2003). Producers, companion animal owners, and others on the front line have a direct personal and private interest in detecting, diagnosing, and preventing animal diseases to avoid losses associated with reduced productivity, animal mortality, or potential effects on personal health and welfare. Although these losses can be significant, adverse social, economic, and human health impacts associated with animal diseases extend beyond producers or household animal owners. Increased investment in educating the public about animal health will help to reduce disease and transmission; enhance public and animal health; ensure a secure, economical, and viable food supply; and improve trade and competitiveness. These educational efforts should include information about diseases of food-animals, wildlife, and companion animals.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary PRIORITIES FOR RESEARCH IN FOOD DEFENSE Francis F. Busta, Ph.D.,4 Shaun Kennedy, B.S.E.,5 and Julie Ostrowsky, M.Sc.6 University of Minnesota–Twin Cities Campus Food defense, dealing with the threat of intentional acts of contamination at any point in the food system, is distinct from food safety, even though the two areas are closely linked. Food safety efforts target unintentional problems, such as “natural” or accidental contamination with microbial (e.g., E. coli or Salmonella) or chemical agents, with some degree of predictability regarding agents, processes, and products of concern. Food defense, by contrast, responds to the threat of sporadic manmade (terrorist) activity, involving high concentrations of contaminants that would not occur naturally or accidentally in the food supply (e.g., B. anthracis, biologically engineered organisms, or chemical toxins). Further, food defense involves dealing with hoaxes or threats sufficient to cause widespread disruption, fear, and panic, and, ultimately, the potential for large-scale, coordinated attacks with catastrophic results. Food defense, unlike food safety, is thereby integral to homeland security, particularly regarding efforts to strengthen critical infrastructure protection, threat assessment, and emergency preparedness and response. The vulnerability of the nation’s food system to terrorist attack (described in the Summary and Assessment and by several workshop contributors, e.g., Osterholm and Henry in Chapter 1; Acheson in Chapter 4) stems from several major factors. The farm-to-table food system encompasses a wide range of inter-dependent elements, from farm inputs, such as seeds and fertilizers, to production, manufacturing and processing, wholesale, distribution, through to the consumer via retail sales and food service. Both domestic and imported ingredients and products move throughout the system. This complexity offers a vast array of potential sites—accessible targets—for intentional contamination to occur. In addition, the degree to which foodborne illness occurs annually (due to “natural” or accidental contamination), despite extensive systems in place to protect the safety of the food supply, underscores the limitations of available food safety efforts. Although necessary to minimize the burden of foodborne illness, those efforts also provide the very information that could be misused deliberately as a roadmap for targeting an attack on the food system. Another major factor is the potentially high impact of a food-related terrorism incident or even an announced threat without an actual attack, given the likelihood of widespread fear and panic in the population and economic devastation to the private sector. 4 Director, National Center for Food Protection and Defense. 5 Deputy Director, National Center for Food Protection and Defense. 6 Senior Program Analyst, National Center for Food Protection and Defense.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary The federal government coordinates food defense activities under the umbrella of the DHS, with sector-specific responsibilities residing jointly with the DHHS and the USDA. Homeland Security Presidential Directive 7 (HSPD-7) issued in 2003 first identified the agriculture and food sector among the nation’s critical infrastructures/key resources singled out for special protection under homeland security initiatives (White House, 2003). In 2004, the Homeland Security Presidential Directive 9 (HSPD-9) established a national policy to protect the food and agriculture system from terrorist attack (White House, 2004). DHS’s National Infrastructure Protection Plan, currently under development, incorporates food and agriculture sector protection among its initiatives to protect the nation’s critical infrastructures and key assets (DHS, 2005a,b; SEMP, 2005). Addressing these critical issues surrounding the potential for food to be exploited as a vehicle for catastrophic attack requires a broad-based, comprehensive approach. Food defense, as a recently defined concept, creates new links among previously unrelated fields. This leads to a diverse, multidisciplinary agenda for food defense research, education, and training. On an operational level, collaborative initiatives across academia, industry, and government are necessary to develop and maintain new channels of communication, leverage resources, and coordinate responsibilities. The effectiveness of food defense efforts will depend on the quality of research outcomes as well as on the successful integration of newly developed technologies, programs, tools, and expertise into public- and private-sector stakeholder communities. This discussion focuses on identifying high-priority areas for research that address two central issues in food defense: preventing major attacks on the food system and responding effectively if such an attack (or credible threats of an attack) were to occur. This research effort is central to the mission of the National Center for Food Protection and Defense (NCFPD), whose program is aimed at reducing the potential for contamination at any point along the food supply chain and mitigating potentially catastrophic public health and economic effects.7 NCFPD Programs NCFPD (2006), led by the University of Minnesota, is one of six academic Centers of Excellence funded through grants from the DHS with the specific 7 Investing in food defense research may well carry significant collateral benefits, beyond its primary value to homeland security, in terms of health and economic effects. Much of what we are learning about preventing and responding to potentially catastrophic attacks on the food system can be applied to ongoing efforts to reduce the burden of foodborne illness caused by more common sources of contamination (natural and accidental). Such advances can also be applied to enhancing routine security operations, such as reduction in the incidence of theft of food products, which commonly occurs all along the supply chain.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary mandate for a food protection and defense center coming from HSPD-9 (DHS, 2004a). Other Homeland Security Centers of Excellence include: Center for Risk and Economic Analysis of Terrorism Events, led by the University of Southern California; National Center for Foreign Animal and Zoonotic Disease Defense, led by Texas A&M University; National Center for the Study of Terrorism and Responses to Terrorism, led by the University of Maryland; Center for the Study of Preparedness and Catastrophic Event Response, led by Johns Hopkins University; and Center for Advancing Microbial Risk Assessment, led by Michigan State University, in collaboration with the U.S. Environmental Protection Agency (EPA) (DHS, 2006). Developed as a multidisciplinary and mission-focused research consortium, NCFPD addresses the vulnerability of the nation’s food system to attack through intentional contamination with biological, chemical or radiological agents. NCFPD takes a comprehensive, farm-to-table view of the food system, encompassing all aspects from primary production through transportation and food processing to retail and food service. In delivering on its mission to defend the safety and security of the food system through research and education, NCFPD places a high priority on threats to the food system that could lead to catastrophic damage to public health or the economy. Academic collaborators in NCFPD’s research consortium include the University of Minnesota, Michigan State University, University of Wisconsin– Madison, North Dakota State University, Georgia Institute of Technology, University of Tennessee–Knoxville, and individual investigators from 21 other universities. Additional research partners are drawn from private-sector research organizations, professional organizations, and food and agriculture agencies. Over 30 industry experts serve as unpaid advisors, providing technical advice, critical end-user feedback, and strategic oversight. To leverage expertise and resources programmatically, close collaboration is maintained with federal and state regulatory agencies, other Homeland Security Centers of Excellence, the national laboratories, and private-sector stakeholders. NCFPD’s program incorporates cutting-edge research aimed at food defense from a variety of disciplines, including supply chain management, logistics, epidemiology, public health, risk assessment, economics, molecular biology, food microbiology, biomedical engineering, toxicology, and risk communication. More than 140 experts in these areas were selected to participate in NCFPD’s research consortium, based on approval of peer-reviewed research proposals submitted by teams of investigators. Thirty-four collaborative research and education projects are currently in progress. A summary of NCFPD initiatives appears in Table 7-1. NCFPD’s program provides a comprehensive framework for identifying priorities and unmet needs in food defense research. Based on the fundamental issues outlined in DHS’s Broad Agency Announcement (DHS, 2004b) calling for proposals for a university Center of Excellence in food protection and defense, NCFPD’s program is organized thematically into three primary areas: systems,

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary TABLE 7-1 National Center for Food Protection and Defense Research Initiatives Strategies for hardening the supply chain Improved outbreak surveillance/investigation approaches for rapid event identification and traceback Realistic models to guide investments and intervention strategy selection for cost-effective preparedness, response, and recovery Detection technologies to rapidly identify contamination to accelerate containment, recall, response, and recovery Inactivation approaches to enable facility recovery now, with preferred options for the future Food handling and processing approaches to reduce the probability of harm Risk communication tools, standards and training to maximize appropriate actions while minimizing fear Educational programs to train the next generation of food system professionals Integrative, transdisciplinary effort spanning the food chain from field to fork Strategic partnerships with all key food system stakeholder groups: Significantly leveraging opportunities Connected to the users to ensure relevance Technology transfer options and multiuse opportunities identified up front Focused on realistic vulnerabilities and real-world solutions; new technologies, tools and approaches SOURCE: Busta (2005). agents, and training. Priorities for research in each of these areas are outlined below. Research Needs: Systems Supply chain security encompasses policies and practices within industry and its regulators to reduce vulnerabilities, minimize disruptions caused by threats or contamination incidents, and maximize the system’s resiliency through effective response plans. Major research needs include the following: Characterizing and benchmarking supply chain security practices, such as basic security processes (e.g., protecting employees), incident management, logistics and transportation security, and companies’ supply chain relationships. Assessing those practices that have the greatest impact on efforts to enhance supply chain security. Developing a common standard for security guidelines within the food industry. Providing strategies for secure communication and information management among federal, state, and industry officials during a potential attack on the food system.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary An effective public health response to incidents of contamination can directly limit the scope of an incident, reduce the risk of foodborne illness, mitigate economic damage, and possibly help deter future attempts. Priorities for research include the following: Develop predictive models and tools to assess the nature, scope, and impact of intentional contamination incidents and responses to those incidents. Improve strategies for coordinating preparedness and response activities across local, state, and federal public health, laboratory, and regulatory jurisdictions. Given the nature of the food system and its interdependency with other sectors of the economy, a deliberate attack on the food system could have broad impacts on the national economy. Estimates of the potential national cost of such attacks are relevant to policy decisions involving the allocation of scarce resources. Research needs include the following: Assess the potential economic impact of a major food system attack on the national economy and on the private sector. Analyze the cost-effectiveness of public, nongovernmental, and industry investment in strategies to enhance supply chain security (e.g., use of “smart seals” or radio frequency identification (RFID) tags to track products through shipment). Evaluate the public’s willingness to support greater public investment in measures to protect the food system from deliberate contamination. Assess the probability of future attacks on the food system. Research Needs: Agents To better recognize foodborne attacks and identify the contaminating agent involved, technologies are needed to sample and detect contaminants in food and to trace contaminated food products (or their ingredients) through the supply chain. Detection of food contaminants is complicated by the food matrix—the chemical and molecular nature of individual foods and the effects of food viscosity, homogeneity, conductivity, and pH on a given agent. Chemical agents present an especially daunting problem because they are difficult to detect and many of them resist food processing designed to safeguard against biological contamination. Existing toxicological tests for chemical agents are limited. Current research aims to take advantage of such properties as chemical class, molecular weight, and solubility as a means to detection. Overall needs for detection include the following:

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary Develop rapid, accurate, and reliable methods to detect select agents and chemical toxins in the food supply. Enable efficient monitoring and testing in a range of food production, processing, distribution, and retail settings. Enhance preanalytical effective preparation of samples for rapid analysis by separation, concentration, and/or purification of select agents from food matrices, recognizing that the complex environments of foods place a premium on preanalytical processes to enable effective detection. Facilitate the rapid translation and integration of newly developed diagnostic research methods into the national laboratory infrastructure, for example by assuring that new methodologies are appropriately validated and by coordinating surge capacity among laboratories during a food contamination incident. Protecting public health in the event of a foodborne attack will involve the decontamination of affected products, people, and physical environments, as well as the safe disposal of contaminated foods. Such processes are managed at the federal level by the EPA and regulated by EPA restrictions on disinfectant use (state level variations are also important). Priorities for research in this area include the following: Develop effective large-scale means of disposing of contaminated food and decontaminating individuals, facilities, or sites. Develop safe and practical methods for neutralizing selected biological agents in food processing facilities and in consumer households. Develop effective protocols for managing disposal, containment, remediation, and recovery processes following a contamination incident. Develop methods to isolate or inactivate potential contaminants, including spores, toxins, and chemical agents, to facilitate detection in the food matrix and to provide a routine level of protection against contamination. Research Needs: Training Preparedness for dealing effectively with a food system attack goes beyond appropriate technical preparation of the first responder groups to include capabilities for rapidly mobilizing and delivering appropriate and credible risk communication messages to the public, as well as prior training of key spokespersons in the public and private sectors. Research needs include the following: Education and training strategies from undergraduate programs through to specialized graduate and professional training to prepare all relevant food system stakeholders with the knowledge and skills to prevent, minimize the consequences of, and recover from a food system attack.

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary Develop guidelines and best practices for active engagement of multiple audiences in effective risk communications prior to, during, and after an intentional food contamination event or hoax. Develop methods to enhance the training of key spokespersons and subject matter experts to improve their risk communication expertise. Effective engagement in food defense efforts at all levels depends critically on the development of a cadre of professionals equipped to deal with this wide array of issues. High-quality education and training programs are needed to expand the pool of available personnel with expertise in food defense. This includes developing just-in-time training materials, advanced course content, virtual training programs, and interdisciplinary degree options for undergraduates, graduates, and professionals. Conclusion Many researchers, including NCFPD collaborators, have broken ground on issues essential to protecting the U.S. food supply and defending it from deliberate contamination. Preventing intentional contamination of the food system requires a shift in mindset: traditional food safety efforts must move from minimizing the possibility of contamination events that can normally happen to preventing those that cannot be permitted to occur. Not only must these efforts be continued and expanded, but to be most effective, their results also need to be shared. Several workshop participants have advocated the creation of a multidimensional database of accumulated knowledge regarding foodborne attack agents, food targets, and detection and decontamination under various conditions. Such a resource could reduce the considerable duplication of research on food defense that occurs in the absence of scientific exchange, and it may also provide a springboard for innovation in the field. REFERENCES Busta F. 2005 (October 26). Session VII: Threat Reduction Research and Policy Opportunities. Presentation at the Forum on Microbial Threats Workshop Meeting, Foodborne Threats to Health: The Policies and Practices of Surveillance, Prevention, Outbreak Investigations, and International Coordination, Washington, D.C., Institute of Medicine, Forum on Microbial Threats. Cohen, JT, Duggar K, Gray GM, Kreindel S, Abdelrahman H, HabteMariam T, Oryang D, and Tameru B. 2003. Revised Risk Assessment: Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States. Harvard Center for Risk Analysis, Harvard School of Public Health. Prepared for the U.S. Department of Agriculture. November 26, 2001, revised October 2003. [Online]. Available: http://www.hcra.harvard.edu/pdf/madcow.pdf [accessed June 27, 2006]. DHS (U.S. Department of Homeland Security). 2004a (January 29). President’s Budget Includes $254 Million to Further Improve Nation’s Bio-Surveillance Capabilities. [Online]. Available: http://www.dhs.gov/dhspublic/display?content=3092 [accessed June 27, 2006].

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Addressing Foodborne Threats to Health: Policies, Practices, and Global Coordination - Workshop Summary DHS. 2004b. Homeland Security Presidential Directive/HSPD-9, Defense of U.S. Agriculture and Food. [Online]. Available: http://www.whitehouse.gov/news/releases/2004/02/20040203-2.html [accessed April 17, 2006]. DHS. 2004c. Broad Agency Announcement. [Online]. Available: http://www.dhs.gov/interweb/assetlibrary/BAA_Agro.doc [accessed April 17, 2006]. DHS. 2005a. Draft National Infrastructure Protection Plan. [Online]. Available: http://www.fas.org/irp/agency/dhs/nipp110205.pdf [accessed April 17, 2006]. DHS. 2005b. Interim National Infrastructure Protection Plan. [Online]. Available: http://www.newsecurityconcepts.com/DataFiles/interim-nipp.pdf [accessed April 17, 2006]. DHS. 2006. Homeland Security Centers of Excellence. [Online]. Available: http://www.dhs.gov/dhspublic/interapp/editorial/ editorial_0498.xml [accessed April 17, 2006]. Haydon DT, Kao RR, and Kitching PK. 2004. The UK foot and mouth disease outbreak—the aftermath. Nature Reviews 2(8):675–681. IOM (Institute of Medicine). 2003. Microbial Threats to Health: Emergence, Detection, and Response. Washington, D.C.: The National Academies Press. NCFPD (National Center for Food Protection and Defense). 2006. NCFPD Homepage. [Online]. Available: http://www.ncfpd.umn.edu/ [accessed April 17, 2006]. NRC (National Research Council). 2004. National Need and Priorities for Veterinarians in Biomedical Research. Washington, D.C.: The National Academies Press. NRC. 2005. Animal Health at the Crossroads. Washington, D.C.: The National Academies Press. SEMP (Suburban Emergency Management Project). 2005. What Is the Interim National Infrastructure Protection Plan? [Online]. Available: http://www.semp.us/biots/biot_200.html [accessed April 17, 2006]. USDA (U.S. Department of Agriculture). 2003 (October 16). Food Market Structures: The U.S. Food and Fiber System. [Online]. Available: http://ers.usda.gov/briefing/foodmarketstructures/foodandfiber.htm [accessed June 27, 2006]. White House. 2003. Homeland Security Presidential Directive HSPD-7. [Online]. Available: http://www.whitehouse.gov/news/releases/2003/12/20031217-5.html [accessed April 17, 2006]. White House. 2004. Homeland Security Presidential Directive HSPD-9. [Online]. Available: http://www.whitehouse.gov/news/releases/2004/02/print/20040203-2.html [accessed April 17, 2006].